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Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of GRANITE, Individualized Neoantigen Vaccine for Solid Tumors

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— Paper reports that Gritstone’s tumor-specific, neoantigen vaccination approach drives priming and boosting of tumor-specific T cells, including cytotoxic CD8+ T cells —

— T cells linked to molecular responses in advanced colorectal cancer (CRC) patients and associated with extended overall survival, which has been observed in follow-up to the Phase 1/2 study —

— GRANITE now in a randomized, controlled Phase 2/3 trial in newly diagnosed metastatic, microsatellite-stable colorectal cancer (MSS-CRC) with initial results expected 2H2023 —

EMERYVILLE, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The paper, “Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results,” details results demonstrating that GRANITE generated strong, persistent, and functional tumor-specific CD4+ and CD8+ T cell responses that have potential broad applicability across a range of disease settings. The published data were originally presented at the European Society for Medical Oncology (ESMO) Congress 2021, and acted as the basis for launching two randomized, controlled studies of GRANITE, including a Phase 2/3 trial that has registrational intent (GRANITE-CRC-1L).

“The publication of this study in Nature Medicine emphasizes the importance, novelty and potential clinical value of the GRANITE program, and reinforces our foundational hypothesis that targeting multiple neoantigens based on each individual tumor’s mutations could drive meaningful clinical benefit, including extended overall survival,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone. “Now we are advancing GRANITE into earlier disease settings, where immune responses are likely stronger, and patients generally have more time for immune destruction of tumors to take effect.”

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Since initiation of the Phase 1/2 study, Gritstone has followed study participants and observed increased overall survival (OS) in colorectal cancer (CRC) patients who demonstrated a molecular response (measured by a reduction in circulating tumor DNA [ctDNA] levels from baseline) versus those who did not. As of May 2022, median OS of this subgroup (treated third-line CRC patients who demonstrated a molecular response) exceeded 18 months with the median not yet reached. This compares to median OS of 7.8 months for patients who did not demonstrate a molecular response, results which are generally consistent with extensive prior data from patients receiving various third-line therapies. Baseline characteristics of these two patient populations are similar. The Phase 1/2 study remains ongoing.

“Personalized neoantigen immunotherapy is a rational approach to treating solid tumor cancers given the abundant evidence that T cells can recognize neoantigens and drive tumor destruction,” said Karin Jooss, Ph.D., Executive Vice President, and Head of R&D. “We have carefully built the GRANITE platform and studied it in a translationally rich clinical program, demonstrating the sequence of desired biological events playing out in advanced cancer patients. Specifically, we showed de novo induction of neoantigen-specific T cells, trafficking of those same T cells to tumors, conversion of cold to hot tumor microenvironments, and key anti-tumor effects such as pseudo-progression, molecular responses, and suggestions of extended overall survival in molecular responders. In a tough tumor type such as metastatic colorectal cancer, these data are sufficiently striking to merit publication in Nature Medicine. We are proud of this accomplishment.”

GRANITE is now being evaluated in two randomized studies in earlier-stage disease; 1) GRANITE-CRC-1L (NCT05141721), a Phase 2/3 trial in newly diagnosed metastatic, microsatellite-stable colorectal cancer (MSS-CRC) that has registrational intent. The first patient was treated in this study in July 2022, and initial results from this study are expected in the second half of 2023. 2) GRANITE-ADJUVANT (NCT05456165), a phase 2 study in patients with high-risk stage II/III colon cancer who are ctDNA+ after definitive surgery.

About GRANITE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens (TSNA), that Gritstone identifies using its proprietary artificial intelligence platform, EDGE™. GRANITE is an individualized neoantigen-based immunotherapy and uses a priming adenoviral vector (GRT-C901) and self-amplifying mRNA vector (GRT-R902) to deliver personalized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC.

About Gritstone
Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to create the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com

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Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on August 4, 2022 and any current and periodic reports filed with the Securities and Exchange Commission.

Gritstone Contacts
Media:
Dan Budwick
1AB
(973) 271-6085
[email protected]

Investors:
George E. MacDougall
Director, Investor Relations & Corporate Communications
Gritstone bio
[email protected] 

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Artificial Intelligence

How AIoT shapes the future of mobility: Hikvision at ITS World Congress 2024

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HANGZHOU, China, Sept. 27, 2024 /PRNewswire/ — Hikvision made a significant impact at the ITS World Congress in Dubai with its captivating theme, “Embrace AIoT for safer, smarter, and greener mobility.” Its booth became a hub of innovation, where visitors explored AIoT solutions that are reshaping the transportation landscape, sparking deep conversations on the future of urban mobility.

Road safety revolution: harnessing AIoT for secure transportation
Hikvision’s commitment to road safety was on full display at its booth through the impressive array of AIoT solutions designed to create secure and reliable traffic environments. The company’s technology provides 24/7 traffic monitoring, ensuring continuous oversight of motor vehicles, non-motorized vehicles, pedestrians and environmental factors. This comprehensive, real-time information collection enables traffic managers to prevent accidents and enhance road safety. Among the showcased products was the 20 MP IR ANPR Checkpoint Capture Unit, renowned for its high-definition capture capabilities, bolstering traffic safety measures.
A standout innovation was the integration of advanced radar and camera technologies, ensuring uninterrupted, comprehensive detection even in adverse weather conditions. The Radar-Video Fusion Incident Detection Cameras, featured prominently in the product experience area, enable early detection and warning of potential hazards. They are particularly effective in challenging situations such as curved roads, blind spots at intersections, and obstacles beyond visual range.
Attendees also engaged with onboard monitoring products on the simulated bus, including dome network cameras, which is designed to enhance passenger safety. Driving assistance products, such as the Driver Status Monitor (DSM), were demonstrated to mitigate unsafe driving behaviors and ensure safer journeys.
Urban mobility redefined: smart traffic innovations
In the realm of smarter mobility, Hikvision showcased its multidimensional sensing technology, which integrates visible light sensors, infrared sensors, radar, and sonar. This technology expands perception capabilities, significantly improving traffic management and situational awareness. The use of AI-powered comprehensive sensing elevates incident monitoring and violation detection to unprecedented levels of accuracy and efficiency.
A major attraction was the Radar-Video Fusion TandemVu PTZ Camera, which integrates millimeter-wave radar with high-resolution cameras for extensive traffic detection and data analysis. AI-based algorithms combine these two systems to enhance target information, detecting up to 16 types of incidents. This leads to the development of a large-scale fusion model that merges spatial physical data with image semantic information. The result is ultra-long-range perception, achieving over 95% accuracy in vehicle trajectory detection. This robust system improves traffic violation management and optimizes traffic flow, significantly enhancing road efficiency.
At the simulated bus station, visitors observed how AI-assisted people counting automated the collection of passenger flow statistics at peak stop hours and bus line frequency during busy periods. Paired with smart bus stop digital signage, the solution improves bus service quality, operational efficiency, passenger experience, and overall public transport effectiveness.
Sustainable transportation: leading the charge for greener cities
Hikvision’s commitment to sustainable urban mobility was evident through its innovative green wave technology and eco-friendly checkpoint solutions. Green wave technology efficiently manages traffic flow to reduce congestion and lower carbon emissions, aligning with global sustainability goals. Visitors were particularly impressed by a case study showcasing a green wave solution implemented in Zhoushan, China. Over a stretch of 21 kilometers and 34 intersections, this main road cut travel times by 50%.
The use of DarkFighterX technology in checkpoint cameras also received significant attention. This technology senses both visible and invisible light, resulting in more accurate and realistic images. It enhances traffic violation enforcement efficiency while minimizing the need for high ambient light levels, thus reducing light pollution. The 9M DarkfightX ANPR Checkpoint Camera exemplified this dedication to environmental stewardship.
Frank Zhang, President of Hikvision MEA, remarked, “Hikvision supports sustainable urban planning by empowering traffic departments to address congestion and transportation challenges.” He further emphasized, “Our system’s openness fosters a secure and reliable platform for developing smart and green cities. Additionally, our solar technology is extensively utilized in remote areas, while our smart street lighting solutions reduce energy consumption by 20-30%, promoting intelligent urban transportation and advancing global sustainability objectives.”
Hikvision’s presence at the ITS World Congress in Dubai underscored its leadership in integrating AIoT technologies to drive safer, smarter, and greener mobility solutions. The engaging presentations and advanced product demonstrations captured significant attention from industry partners and customers, reaffirming the company’s role as a pioneer in shaping the future of urban transportation. As the world moves towards more intelligent and sustainable transportation systems, Hikvision remains at the forefront, embracing AIoT to create a safer, smarter, and greener future for all.
To find out more about Hikvision’s advanced traffic and public transport solutions, please explore the Hikvision official website.
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Anti-Drone Market worth $7.05 billion by 2029 – Exclusive Report by MarketsandMarkets™

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DELRAY BEACH, Fla., Sept. 27, 2024 /PRNewswire/ — The global anti-drone market was valued at USD 2.16 billion in 2024 and is projected to reach USD 7.05 billion by 2029; it is expected to register a CAGR of 26.7% during the forecast period according to a new report by MarketsandMarkets™. Increasing government spending on counter-drone technologies, rising incidence of critical infrastructure security breaches by unauthorized drones, and surge in adoption of aerial remote sensing technologies to safeguard critical infrastructure are attributed to the demand for anti-drone.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=177013645
Browse in-depth TOC on “Anti-Drone Market” 178 – Tables61 – Figures253 – Pages
Anti-Drone Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 2.16 billion
Estimated Value by 2029
$ 7.05 billion
Growth Rate
Poised to grow at a CAGR of 26.7%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By System Type, Application, Platform type, Vertical, and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Vulnerability to hacking
Key Market Opportunities
Emphasis on improving unmanned aircraft systems technology
Key Market Drivers
Growing number of illicit activities
By System Type: Hybrid systems to account for the larger market share in the forecasted year.
The hybrid segment accounted for the largest share of the anti-drone market in 2029. The trends of integrating multiple anti-drone technologies are rising since they are most effective in detecting, tracking, and neutralizing drone threats. These systems merge electronic, kinetic, and lasers, providing a comprehensive defense solution against UAVs. Hybrid systems use electronic, kinetic, and laser-based countermeasures to offer optimum protection against drones. These systems are designed to detect, track, identify, categorize, and mitigate drones at operational wide ranges ranging from a few km up to tens of km.
By Platform: The ground-based segment accounted for the largest market share in the forecast year.
The ground-based segment will hold a major share of the anti-drone market in 2029. Many ground-based anti-drone systems use several electronic technologies, such as radar, IR sensors, acoustic systems, and RF & GNSS jammers. MESA radar solutions are used mostly for counter-UAS purposes, protecting critical infrastructure, military camps, and other security-sensitive sites from unauthorized drones. One such solution is EchoGuard, a ground-based airspace management solution that contains a software-defined 3D radar that can be specific to the site. This system can identify single or multiple off-chance drones, including swarms in unauthorized areas. They provide accurate and sustained airspace surveillance for the field of view (FOV) they are configured, and both human and AI-monitored visual checks. The system can be easily transported and integrated directly with the command-and-control centers or another identification sensor for portable use, and multiple units of the system can be combined to cover vast areas or lengths of borders. Major providers of ground-based counter-drone systems include companies like EchoDyne Corporation, DeTect, Meteksan Defense, and WhiteFox Defense. Acoustics-based Discovair G2 utilizes patented microphone arrays. With 128 interconnected microphone elements, the Discovair sensor units can establish azimuth and elevation to the target in real-time using advanced digital signal processing.
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By Region: Americas are expected to hold the largest share of the anti-drone market during the forecast period.
Americas is expected to capture the largest share in the anti-drone industry during the forecast period. The growth can be attributed to protecting crucial infrastructure in the region. Governments, particularly in the US, invest in anti-drone systems for military bases, borders, and critical infrastructure. For Instance, in April 2023, RTX secured a USD 237 million contract from the US Army to provide Ku-band Radio Frequency Sensors (KuRFS) and Coyote effectors. These systems are designed to detect and neutralize unmanned aircraft systems (UAS). The contract includes stationary and mobile systems and a specified quantity of effectors, all aimed at enhancing the Army’s operations within the US Central Command region.
Key Players-
The key companies offering anti-drone companies include RTX (US), Lockheed Martin Corporation (US), Leonardo S.p.A. (Italy), Thales (France), and IAI (Israel).
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Browse Adjacent Market: Semiconductor and Electronics Market Research Reports &Consulting
Related Reports: 
Drone Sensor Market Size, Share, Industry Growth & Trends by Sensor Type, Platform (VTOL Type, Fixed Wing Type, Hybrid Type), Application (Navigation, Collision Detection & Avoidance, Data Acquisition, Motion Detection, Power Monitoring), End Users and Region – Global Forecast to 2029
Smart Agriculture Market Size, Share, Statistics and Industry Growth Analysis Report by Offering (Hardware, Software, Services), Agriculture Type, Farm Size (Large, Medium, Small), Application (Precision Farming, Livestock Monitoring) and Region (America, Europe, Asia Pacific, Row) – Global Forecast to 2028
About MarketsandMarkets™
MarketsandMarkets™ has been recognized as one of America’s best management consulting firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.
Earlier this year, we made a formal transformation into one of America’s best management consulting firms as per a survey conducted by Forbes.
The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the ‘GIVE Growth’ principle, we work with several Forbes Global 2000 B2B companies – helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.
Contact: Mr. Rohan SalgarkarMarketsandMarkets™ INC. 1615 South Congress Ave.Suite 103, Delray Beach, FL 33445USA: +1-888-600-6441Email: [email protected] Our Web Site: https://www.marketsandmarkets.com/Research Insight: https://www.marketsandmarkets.com/ResearchInsight/anti-drone-market.aspContent Source: https://www.marketsandmarkets.com/PressReleases/anti-drone.asp
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CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

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CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest addition to its enterprise software platform.
KING OF PRUSSIA, Pa., Sept. 27, 2024 /PRNewswire/ — CluePoints continues to transform clinical trial review and leverage its industry-leading software to enhance the interrogation, analysis and presentation of data with the launch of its latest application, Medical & Safety Review (MSR).

The tool simplifies and streamlines the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history. This not only improves efficiency and communication in medical oversight, but also elevates patient safety, differentiating MSR as a smarter and unique solution.
Designed by, and for Medical and Safety Reviewers, MSR converts the manual analysis of patient outcomes, which can be prone to inefficiency and error, into an accurate, efficient process. MSR tackles time-consuming study preparation for specific visualizations by featuring a comprehensive standard visualization library as well as the ability to copy and reuse dashboards across different studies, enabling the identification of outlying values, change tracking, and improved communication for smarter clinical trials.
Other benefits of MSR include:
Enhanced medical review efficiency and reduced human errors via automated checksReduced time spent by clinical and data management teams in reviewing dataImproved collaboration with integrated review workflows across departmentsEnsured record quality and accountability with comprehensive change trackingDriving faster decision making with the proactive detection of trends and safety issuesEnsuring regulatory compliance with rule-based detection and user assignmentsAndy Cooper, Chief Executive Officer at CluePoints, commented, “We are thrilled to announce the launch of Medical & Safety Review to our growing product offerings. MSR is the latest application addition to the CluePoints platform, which includes products such as Risk-Based Quality Management (RBQM) and our Site Profile & Oversight Tool (SPOT). Together, they provide a comprehensive approach to clinical trial optimization, enhancing data integrity, ensuring regulatory compliance, and accelerating drug development. The creation of MSR ensures a more streamlined review process while prioritizing patient safety at every step and empowers medical teams to swiftly identify outliers, track data changes, and improve communication.”
To learn more about CluePoints’ award-winning solutions, please visit www.cluepoints.com
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
 

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